Implant Experience with an Implantable Hemodynamic Monitor for the Management of Symptomatic Heart Failure

doi:10.1111/j.1540-8159.2005.00176.x

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Wiley InterScience

Pacing and Clinical Electrophysiology

Volume 28 Issue 8, Pages 747 - 753

Published Online: 11 Aug 2005

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Implant Experience with an Implantable Hemodynamic Monitor for the Management of Symptomatic Heart Failure

DAVID STEINHAUS*, DWIGHT W. REYNOLDS†, FREDRIK GADLER‡, G. NEAL KAY£, MIKE F. HESS§, and TOM BENNETT§ ( For The Chronicle Investigators )

From the *Mid-America Heart Institute, Kansas City, Missouri , †University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma , ‡Cardiology Department, Karolinska Hospital, Stockholm, Sweden , £University of Alabama at Birmingham, Birmingham, Alabama , and §Medtronic Inc., Minneapolis, Minnesota

Correspondence to Address for reprints: Tom Bennett, Ph.D., Heart Failure Research, Medtronic, Inc., MS CW320, 7000 Central Ave. NE, Minneapolis, MN 55432. Fax: 763-514-8347; e-mail: tom.bennett@medtronic.com

Coauthors, Mr. Hess and Dr. Bennett, are employees of Medtronic, Inc., the sponsor for the studies reported in this article. The devices reported are limited to investigational use only.

KEYWORDS

congestive heart failure • implantable hemodynamic monitor • hemodynamic monitoring • sensor lead • intracardiac pressure • device implant

STEINHAUS, D., et. al.: Implant Experience with an Implantable Hemodynamic Monitor for the Management of Symptomatic Heart Failure.

(PACE 2005; 28:747–753)

ABSTRACT

Introduction: Management of congestive heart failure is a serious public health problem. The use of implantable hemodynamic monitors (IHMs) may assist in this management by providing continuous ambulatory filling pressure status for optimal volume management.

Methods and Results: The Chronicle^® system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The tip of the lead is placed near the right ventricular outflow tract to minimize risk of sensor tissue encapsulation. Implant technique and lead placement is similar to that of a permanent pacemaker. After the system had been successfully implanted in 148 patients, the type and frequency of implant-related adverse events were similar to a single-chamber pacemaker implant. R-wave amplitude was 15.2 ± 6.7 mV and the pressure waveform signal was acceptable in all but two patients in whom presence of artifacts required lead repositioning. Implant procedure time was not influenced by experience, remaining constant throughout the study.

Conclusion: Based on this evaluation, permanent placement of an IHM in symptomatic heart failure patients is technically feasible. Further investigation is warranted to evaluate the use of the continuous hemodynamic data in management of heart failure patients.

Received February 15, 2005; revised April 4, 2005; accepted April 4, 2005.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1540-8159.2005.00176.x About DOI